Removable middle ear implant sensor

ABSTRACT

A middle ear implant includes a first interface portion configured to interface with a first structure of a middle ear of a patient, a second interface portion configured to interface with a second structure of the middle ear of the patient, a shaft that connects the first and second interface portions, a carrier plate removably mounted in one of the first or second interface portions, and a removable sensor disposed at one end of the shaft, between the shaft and one of the first interface portion or the second interface portion. The removable sensor is configured to provide a DC signal output indicative of static pressure on the sensor based on placement of the sensor between the first and second structures, and provide an AC signal output indicative of a frequency response of the implant. The removable sensor is disposed at a portion of the carrier plate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of co-pending U.S. Nonprovisionalapplication Ser. No. 14/857,963 filed on Sep. 18, 2015, which claims thebenefit of U.S. Provisional Application No. 62/054,403 filed on Sep. 24,2014, the entire content of both of which are hereby incorporated hereinby reference.

TECHNICAL FIELD

Exemplary embodiments of the present disclosure generally relate tohearing implant technology, and more specifically relate to a sensorthat may be used to test the efficacy of a middle ear implant in situ.

BACKGROUND

Over 36 million Americans currently suffer from significant hearingloss. Numerous diseases and traumas can cause conductive hearing loss.Prevalent among these are: Cholesteotoma (bone/joint degeneration of themiddle ear bones), mechanical trauma (exposure to exceedingly loudsounds), and barotraumas (exposure to the shock front of an explosiveblast or supersonic projectile). Conductive hearing loss (CHL) occursdue to disarticulation of the ossicular chain.

Various types of ear implant surgeries have been developed to facilitatethe mitigation or treatment of hearing loss. Some of these surgeriesinvolve the installation of prosthetic implants into the middle ear ofpatients suffering from hearing loss. For many of the surgicalprocedures employed to install these prosthetic implants, the surgeonrelies merely on an intuitive feel to provide proper placement and/oradjustment of components of the prosthetic implant. This means that,even for experienced surgeons, sub-optimal outcomes can be fairly commonand placement of the prosthesis ends up being less than ideal.Accordingly, the implantation surgery may need to be repeated forimproved placement. This, of course, increases cost. However, somepatients may also be reluctant to engage in further procedures or maynot recognize that further optimization is possible.

Accordingly, there is a need to develop an ability to monitor theeffective placement of prosthetic implants during the surgicalprocedures in order to improve outcomes for patients.

BRIEF SUMMARY OF SOME EXAMPLES

Some example embodiments may enable the provision of a system capable ofevaluating the installation of a prosthetic implant during the surgicalprocess. In this regard, by providing a sensor in the implant, exampleembodiments may enable the installation of some implants to be monitoredfor such things as, for example, proper adjustment and positioning.Rather than waiting for months after surgery to obtain audiologyreports, surgeons may be able to monitor installation and expectedresponse parameters based on the current situation and provide betterinstallation results. However, in order to avoid complications that maybe created by governmental regulations related to the testing andevaluation of components that remain in the body, some exampleembodiments may further provide that the sensor is a removable sensor sothat after evaluation of placement and/or any desirable adjustments aremade, the removable sensor may be removed from the implant.

In one example embodiment, a middle ear implant is provided. The middleear implant may include a first interface portion configured tointerface with a first structure of a middle ear of a patient, a secondinterface portion configured to interface with a second structure of themiddle ear of the patient, a shaft configured to connect the firstinterface portion and the second interface portion, a carrier plateconfigured to be removably mounted in one of the first interface portionor the second interface portion, and a removable sensor disposed at oneend of the shaft, between the shaft and one of the first interfaceportion or the second interface portion. The removable sensor isconfigured to provide a DC signal output indicative of static pressureon the sensor based on placement of the sensor between the first andsecond structures, and provide an AC signal output indicative of afrequency response of the implant. The removable sensor is disposed at aportion of the carrier plate.

In another example embodiment, a test set is provided. The test set mayinclude a meter and a middle ear implant. The middle ear implant mayinclude a first interface portion configured to interface with a firststructure of a middle ear of a patient, a second interface portionconfigured to interface with a second structure of the middle ear of thepatient, a shaft configured to connect the first interface portion andthe second interface portion, a carrier plate configured to be removablymounted in one of the first interface portion or the second interfaceportion, and a removable sensor disposed at one end of the shaft,between the shaft and one of the first interface portion or the secondinterface portion. The removable sensor is configured to provide a DCsignal output indicative of static pressure on the sensor based onplacement of the sensor between the first and second structures, andprovide an AC signal output indicative of a frequency response of theimplant. The removable sensor is disposed at a portion of the carrierplate. The meter may be configured to interface with the sensor duringthe surgical procedure to provide indications to an operator regardingthe DC and AC signal outputs.

In still another example embodiment, a method of employing a sensor forproviding feedback on implant placement during surgical procedures for amiddle ear implant is provided. The method may include placing theremovable sensor on a carrier plate that is insertable within a portionof the implant, installing the carrier plate into the portion of theimplant with communication to a test set, and placing the implant in themiddle ear of a patient. The method further comprises detecting a DCcomponent at the meter indicative of static pressure placed on theremovable sensor based on its placement in the middle ear, detecting anAC component at the meter indicative of frequency response of theimplant, removing the carrier plate from the implant to enable removalof the removable sensor from the carrier plate, and reinstalling thecarrier plate into the portion of the implant.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Having thus described the invention in general terms, reference will nowbe made to the accompanying drawings, which are not necessarily drawn toscale, and wherein:

FIG. 1 illustrates a conceptual view of the middle ear of a patientemploying an implant device in accordance with an example embodiment;

FIG. 2A illustrates an exploded, perspective view of the implant inaccordance with an example embodiment;

FIG. 2B illustrates a cross sectional view of the implant in accordancewith an example embodiment;

FIG. 2C illustrates a side view of a second interface portion of theimplant looking into a reception slot in accordance with an exampleembodiment;

FIG. 2D illustrates a top view of a carrier plate in accordance with anexample embodiment;

FIG. 2E illustrates a cross section view of the carrier plate of FIG. 2Dalong the longitudinal axis of the carrier plate in accordance with anexample embodiment;

FIG. 2F illustrates a side view of the carrier plate from a perspectivealong the longitudinal axis of the carrier plate in accordance with anexample embodiment;

FIG. 3 illustrates a block diagram of a test set for use whileinstalling the implant in accordance with an example embodiment; and

FIG. 4 illustrates a block diagram of a method of employing a sensor forproviding feedback on implant placement during surgical procedures for amiddle ear implant in accordance with an example embodiment.

DETAILED DESCRIPTION

Some example embodiments now will be described more fully hereinafterwith reference to the accompanying drawings, in which some, but not allexample embodiments are shown. Indeed, the examples described andpictured herein should not be construed as being limiting as to thescope, applicability or configuration of the present disclosure. Rather,these example embodiments are provided so that this disclosure willsatisfy applicable legal requirements. Like reference numerals refer tolike elements throughout.

A removable sensor, and corresponding system, for evaluating theinstallation of a prosthetic implant during the surgical process isprovided. In this regard, the removable sensor can be provided within aportion of the implant to enable proper adjustment and positioning to bemonitored prior to removal of the removable sensor. In some cases, theremovable sensor can be provided within a portion of the implant and canbe tested during the surgical procedure to measure both the load on theimplant and the frequency response of the implant. Accordingly, forexample, surgeons may be able to test and adjust, if needed, duringinstallation. As such, response parameters and loading may be monitoredduring installation so that provide better installation results can beachieved without waiting for months after surgery to obtain audiologyreports. The removable sensor is therefore configured to providereal-time data indicative of output parameters generated based onplacement of the implant in the middle ear during a surgical procedureso that adjustments can be made as necessary to improve placement forbetter likelihood of successful hearing loss mitigation. Thereafter, theremovable sensor can be easily removed so that there is no sensor leftin the inner ear and testing and regulation compliance associated withleaving such a sensor in the ear can be avoided.

FIG. 1 illustrates a conceptual view of the middle ear of a patientemploying a device in accordance with an example embodiment. In thisregard, as shown in FIG. 1, an outer ear 100 and ear canal 110 maydirect sound energy in toward the ear drum 120. Movement at the ear drum120 may be transferred to the malleus 130 (or hammer). Normally, themalleus 130 may transfer sound energy to the incus (or anvil—not shown),which further transfers the sound energy to the stapes (or stirrup) 140.From the stapes 140, sound energy is transferred to the cochlea 150 orinner ear, where the sound pressure patterns are converted to electricalimpulses that can be transmitted to the brain via the auditory nerve160.

In cases where a bone of the inner ear (i.e., the malleus 130, incus orstapes 140) is non-functional (or at least functioning improperly) dueto disease, damage or defect, it may be possible to replace thecorresponding bone (or bones) with a prosthetic implant. Such an implantmay generally be provided to function in a similar manner to the bonethat is to be replaced. In the present example, the incus may have beenmissing, damaged or otherwise non-functional and a prosthesis (orimplant 170) may be provided to bridge the distance between the malleus130 and the stapes 140. The implant 170 may be surgically installedbetween the malleus 130 and the stapes 140 and placed under load due tothe pressure between the malleus 130 and the stapes 140.

The mere replacement of a damaged incus with the implant 170 may beperformed substantially using conventional techniques. However, inaccordance with an example embodiment, the implant 170 may have sensortechnology employed therein that may enable the loading and frequencyresponse of the implant 170 to be monitored prior to completion of theinstallation surgical procedure. The sensor technology may enable thesurgeon to have the loading checked to determine whether it falls withinan acceptable range, and may allow a stimulus to be applied to theimplant 170 so that frequency response of the implant 170 may bemonitored, again relative to acceptable levels. In an exampleembodiment, the sensor installed with the implant 170 may generate avoltage proportional to the compression force between the malleus 130and the stapes 140. The voltage may be measured to enable thepositioning of the implant 170 to be optimized. Additionally, acoustictransmission characteristics may be evaluated prior to completing theimplantation surgery. Thereafter, the sensor may be removed.

It should be appreciated that although a particular implant (i.e.,implant 170) for replacement of the incus is described herein, exampleembodiments may also be used in connection with other specific implantswhere the design features described herein remain applicable. Thus, theimages and descriptions provided herein should be appreciated as beingprovided for purposes of enabling the description of an example and notfor purposes of limitation.

FIG. 2, which includes FIGS. 2A, 2B, 2C, 2D and 2F, illustrates theimplant 170 of an example embodiment in greater detail. In this regard,FIG. 2A illustrates an exploded, perspective view of the implant 170 inaccordance with an example embodiment. Meanwhile, FIG. 2B illustrates across sectional view of the implant 170 in accordance with an exampleembodiment. FIG. 2C illustrates a side view of a second interfaceportion of the implant looking into a reception slot in accordance withan example embodiment. FIG. 2D illustrates a top view of a carrier platein accordance with an example embodiment. FIG. 2E illustrates a crosssection view of the carrier plate of FIG. 2D along the longitudinal axisof the carrier plate in accordance with an example embodiment. FIG. 2Fillustrates a side view of the carrier plate from a perspective alongthe longitudinal axis of the carrier plate in accordance with an exampleembodiment.

Referring primarily to FIGS. 2A and 2B, the implant 170 may includefirst interface portion 200, a shaft 210 and a second interface portion220. The implant 170 may also include a removable sensor 230 that may beprovided between the shaft 210 and the second interface portion 220. Itshould be appreciated, however, that the removable sensor 230 couldalternatively be located between the first interface portion 200 and theshaft 210 or at any other suitable location of a differently structuredimplant.

The first and second interface portions 200 and 220 may be structured inany suitable fashion. However, given that the implant 170 of thisexample embodiment replaces the incus, the first interface portion 200may be somewhat larger and have a disc shape to facilitate interfacingwith the malleus 130 over a relatively larger surface area, while thesecond interface portion 220 has a cylindrical shaped terminus tofacilitate interfacing with the stapes 140 over a relatively smallersurface area. In an example embodiment, the first interface portion 200may be formed of an annular portion 202 that extends around a discportion 204 to facilitate expanding the surface area of the firstinterface portion 200. In some cases, one or more axial support membersmay extend axially outward from the disc portion 204 to engage and holdthe annular portion 202 so that the disc portion 204, the annularportion 202 and any axial support members are substantially coplanarwithin a plane that lies substantially perpendicular to the direction ofextension of the shaft 210. The disc portion 204 may further include areceiving portion 206 that may extend around a portion of the shaft 210to receive the shaft 210. As such, the receiving portion 206 may form orinclude a hollow cylinder extending in the direction of extension of theshaft 210 to receive a proximal end of the shaft 210 within the hollowcylinder of the receiving portion 206.

The shaft 210 may extend away from a center of the disc portion 204 and,in some cases, may define an axial centerline of the disc portion 204.The shaft 210 may extend toward the second interface portion 220 and adistal end of the shaft 210 may terminate in the second interfaceportion 220. As shown in FIG. 2A, the second interface portion 220 mayinclude a receiving opening 240 configured to receive the distal end ofthe shaft 210. Thus, the shaft 210, which may have a cylindrical shape,may be received within a cylindrically shaped orifice formed in thesecond interface portion 220, and forming the receiving opening 240.However, it should be appreciated that any corresponding shapes could beemployed in alternative embodiments.

The shaft 210 may be inserted into the receiving opening 240 and extendinto the second interface portion 220 along a longitudinal centerline ofthe second interface portion 220. Thus, the longitudinal centerlines ofthe shaft 210 and the second interface portion 220 may be aligned whenthe shaft 210 is inserted into the second interface portion 220. Thesecond interface portion 220 may include a reception slot 250 disposedin a sidewall thereof and extending into the interior of the secondinterface portion 220 to intersect or pass through the longitudinalcenterline of the second interface portion 220. The reception slot 250,which is shown in FIGS. 2A and 2C, may form a receiving orifice that hasrelatively shorter sidewalls 221 that extend substantially parallel tothe longitudinal centerline of the second interface portion 220 and mayhave floor 222 and ceiling 223 walls that are opposite each other andextend substantially perpendicular to the longitudinal centerline of thesecond interface portion 220. In an example embodiment, a distancebetween floor 222 and ceiling 223 may be about 0.003 inches, and adistance between the sidewalls 221 may be about 0.016 inches. Thus, thereception slot 250 may have a relatively flat shape that substantiallymatches the shape of a carrier plate 260 that is insertable into thereception slot 250.

The carrier plate 260, which is shown in greater detail in FIGS. 2D, 2Eand 2F, may be substantially plate shaped, with length, width and depthcharacteristics that correspond to, or at least allow the carrier plate260 to fit within, the reception slot 250. In some cases, an outer edge261 of the carrier plate 260 may be shaped to correspond to the outersidewall of the second interface portion 220. Thus, the carrier plate260 may be insertable into and removable from the reception slot 250 byan operator (e.g., a surgeon). The removable sensor 230 may be providedat a holding slot 262 formed at a portion of the carrier plate 260 thataligns with the receiving opening 240 when the carrier plate 260 isinserted into the reception slot 250. In some embodiments, the carrierplate 260 may include a slanted floor 263 that at least partiallysurrounds portions of the holding slot 262 so that when the shaft 210 isseated within the receiving opening 240 against the removable sensor230, the carrier plate 260 is retained in the reception slot 250 andprevented from sliding out of the reception slot 250 (e.g., in thedirection of arrow 395 of FIG. 3 below). The removable sensor 230 istherefore substantially enclosed within the assembled combination of theshaft 210, the carrier plate 260 and the second interface portion 220.As such, the removable sensor 230 may be arranged to lie in a plane thatis substantially perpendicular to the direction of extension of theshaft 210 and substantially parallel to the plane in which the discportion 204, the annular portion 202 and any axial support members ofthe first interface portion 200 may lie. The removable sensor 230 mayalso lie in a plane that is substantially parallel to the planes inwhich the ceiling and floor of the reception slot 250 lie, andsubstantially parallel to the plane in which the carrier plate 260 lies,when inserted into the reception slot 250.

In an example embodiment, the first and second interface portions 200and 220 and the shaft 210 may be made of a rigid material that issuitable for long term insertion into the human body without adverseaffects. The insertion area into which the implant 170 is provided isoften as small as 3 mm, thus, the material must be capable of beingmachined, molded or otherwise produced with great accuracy at arelatively small size. In some cases, Titanium may be employed as amaterial of which some or all of the components of the implant 170 maybe made. However, alternative metals or composite materials are alsocandidates for use, and it is not necessarily required that all portionsof the implant 170 be made from the same material. The reception slot250 may be machined or formed in the molding process.

The removable sensor 230 may be formed of a sheet or mat of materialhaving a relatively thin depth dimension. For example, some exampleembodiments may employ a film or fiber structure having a thickness ofabout 40 microns. In some embodiments, the removable sensor 230 may beembodied as a piezoelectric Poly (γ-benzyl α, L-glutamate) (PBLG) filmor fiber sensor that forms a sensing layer that can be inserted into thefloor of the receiving opening 240. Any force transmitted along theshaft 210 may then be sensed at the sensing layer forming the removablesensor 230. In some embodiments, the sensing layer may be formed usingpiezoelectric nanofibers, as a patterned polymeric piezoelectriccomposite film, or as a contoured/dome-shaped sample having transductionproperties.

In an example embodiment, the removable sensor 230 may therefore beformed of an active sensing material that can generate electricalimpulses based on mechanical stimuli. However, the primary function ofthe removable sensor 230 may be to provide feedback on implant 170placement during a surgical procedure, and the removable sensor 230 maytherefore essentially cease to be necessary after the surgical procedureis completed. As such, the removable sensor 230 may be integrated aspart of a testing system with electrical leads attached to theelectrodes on the top and bottom of the sensor layer forming the sensormaterial 230 at some point during the surgical procedure. However, theelectrical leads may be removed either with or without the removablesensor 230 when the removable sensor 230 is removed. In one example, theelectrical leads may be removed from contact with the electrodes and theremovable sensor 230 may then separately be removed from the implant 170thereafter (e.g., by removal of the carrier plate 260). In anotherexample, the electrical leads may be attached to the removable sensor230 in such a way that permits the electrical leads to be removed alongwith removal of the removable sensor 230. Moreover, in some cases,pressure may be put on the electrical leads to withdraw the removablesensor 230 (along with the carrier plate 260) from the reception slot250. Then, after the removable sensor 230 is removed, the carrier plate260 may be reinserted into the second interface portion 220 so that theshaft 210 terminates at about the same position within the secondinterface portion 220 as the shaft 210 had terminated at when theremovable sensor 230 was installed. Due to the relatively thin nature ofthe removable sensor 230, and the fact that the removable sensor 230lies at the floor of the receiving opening 240 on a surface of thecarrier plate 260, the shaft 210 and the second interface portion 220may generally interface with each other at the same location regardlessof whether the removable sensor 230 is present.

FIG. 3 illustrates a block diagram of a test set 300 for use whileinstalling the implant 170 in accordance with an example embodiment. Asshown in FIG. 3, the test set 300 may include the removable sensor 230placed in the implant 170 via the carrier plate 260. Electrical leads310 may be in communication with top and bottom sides, respectively, ofthe sensor layer forming the removable sensor 230. The electrical leads310 may be provided to a meter 320 configured to monitor electricalsignals generated by the removable sensor 230. In some cases, the testset 300 may further include an excitation unit 330 that may beconfigured to generate one or more test signals 340 that can beintroduced to the middle ear of the patient in order to monitor theresponse to the test signals 340 at the removable sensor 230 via themeter 320.

In an example embodiment, a control unit 350 may further be provided tocontrol and/or coordinate operation of the test set 300. As such, forexample, the control unit 350 may be used to enable the operator tocontrol application of and/or define parameters of the test signals 340.The control unit 350 may also or alternatively monitor outputs detectedat the meter 320 and conduct analysis of the outputs to enable thesurgeon or other operator to determine whether the output parameterssensed at the removable sensor 230 (i.e., the electrical impulsesdetected in response to the mechanical input provided by in the form ofthe test signals) are within acceptable ranges for the test signals 340provided.

As such, for example, the test signals 340 may be one or more soundinputs that may have known parameters or characteristics, and thecontrol unit 350 may store data indicative of an acceptable range ofoutput parameters for given input parameters. The output parameters mayinclude an AC signal indicative of frequency response characteristics ofthe implant 170 based on its present location. Meanwhile, the pressureor static load 345 placed upon the implant 170 by the bones or otherfeatures between which the implant 170 is placed may also generate anelectrical impulse. The output generated based on the static load 345may be represented as a DC signal indicative of the pressure loadbetween the bones that the implant 170 contacts.

The control unit 350 may include processing circuitry 355 configured toexecute instructions for control of the excitation unit 330 and/or foranalysis of the output parameters detected at the meter 320. Theprocessing circuitry 355 may be configured to perform data processing,control function execution and/or other processing and managementservices according to an example embodiment of the present invention. Insome embodiments, the processing circuitry 355 may be embodied as a chipor chip set. In other words, the processing circuitry 355 may compriseone or more physical packages (e.g., chips) including materials,components and/or wires on a structural assembly (e.g., a baseboard).

In an example embodiment, the processing circuitry 355 may include oneor more instances of a processor 360 and memory 365 that may be incommunication with or otherwise control a device interface. As such, theprocessing circuitry 355 may be embodied as a circuit chip (e.g., anintegrated circuit chip) configured (e.g., with hardware, software or acombination of hardware and software) to perform operations describedherein. The processing circuitry 355 may further interface with a userinterface 370 and/or a device interface 380 of the control unit 350.

The device interface 380 may include one or more interface mechanismsfor enabling communication with other external devices (e.g., outputdevices, input devices, and/or the like) or the modules/components ofthe test set 300. In some cases, the device interface 380 may be anymeans such as a device or circuitry embodied in either hardware, or acombination of hardware and software that is configured to receiveand/or transmit data from/to devices and/or modules in communicationwith the processing circuitry 355. Thus, the device interface 380 mayenable the processor 360 to communicate with the excitation unit 330and/or the meter 320.

In an exemplary embodiment, the memory 365 may include one or morenon-transitory memory devices such as, for example, volatile and/ornon-volatile memory that may be either fixed or removable. The memory365 may be configured to store information, data, applications,instructions or the like for enabling the processing circuitry 355 tocarry out various functions in accordance with exemplary embodiments ofthe present invention. For example, the memory 365 could be configuredto buffer input data for processing by the processor 360. Additionallyor alternatively, the memory 365 could be configured to storeinstructions for execution by the processor 360. As yet anotheralternative, the memory 365 may include one or more databases that maystore a variety of excitation patterns and/or data sets indicative ofspecific test signals 340 for input and corresponding acceptable outputparameters and/or acceptable static load parameters that may be employedfor the execution of example embodiments. Among the contents of thememory 365, applications may be stored for execution by the processor360 in order to carry out the functionality associated with eachrespective application. In some cases, the applications may includedirections for control of the excitation unit 330 and/or processing andanalysis of data received at the meter 320 so that an output can beprovided to the operator at the user interface 370.

The processor 360 may be embodied in a number of different ways. Forexample, the processor 360 may be embodied as various processing meanssuch as one or more of a microprocessor or other processing element, acoprocessor, a controller or various other computing or processingdevices including integrated circuits such as, for example, an ASIC(application specific integrated circuit), an FPGA (field programmablegate array), or the like. In an example embodiment, the processor 360may be configured to execute instructions stored in the memory 365 orotherwise accessible to the processor 360. As such, whether configuredby hardware or by a combination of hardware and software, the processor360 may represent an entity (e.g., physically embodied in circuitry—inthe form of processing circuitry 355) capable of performing operationsaccording to embodiments of the present invention while configuredaccordingly. Thus, for example, when the processor 360 is embodied as anASIC, FPGA or the like, the processor 360 may be specifically configuredhardware for conducting the operations described herein. Alternatively,as another example, when the processor 360 is embodied as an executor ofsoftware instructions, the instructions may specifically configure theprocessor 360 (which could in some cases otherwise be a general purposeprocessor) to perform the operations described herein.

In an example embodiment, the processor 360 (or the processing circuitry355) may be embodied as, include or otherwise control the modules of thecontrol unit 350. As such, in some embodiments, the processor 360 (orthe processing circuitry 355) may be said to cause each of theoperations described in connection with the modules of the control unit350 to undertake the corresponding functionalities responsive toexecution of instructions or algorithms configuring the processor 360(or processing circuitry 355) accordingly.

The user interface 370 (if implemented) may be in communication with theprocessing circuitry 355 to receive an indication of a user input at theuser interface 370 and/or to provide an audible, visual, mechanical orother output to the user. As such, the user interface 370 may include,for example, a display, printer, one or more buttons or keys (e.g.,function buttons), and/or other input/output mechanisms (e.g., keyboard,touch screen, mouse, microphone, speakers, cursor, joystick, lightsand/or the like). The user interface 370 may display informationregarding control unit 350 operation. The information may then beprocessed and further information associated therewith may be presentedon a display of the user interface 370 based on instructions executed bythe processing circuitry 355 for the analysis of the data according toprescribed methodologies and/or algorithms. Moreover, in some cases, theuser interface 370 may include options for selection of one or morereports to be generated based on the analysis of a given data set.Interface options (e.g., selectable instructions, or mechanisms by whichto define instructions) may also be provided to the operator using theuser interface 370.

As mentioned above, the test set 300 may be employed during an operationto enable the operator to adjust the location or placement of theimplant 170 based on output parameters detected at the meter 320. Inthis regard, the static load 345 may generate a DC signal output fromthe removable sensor 230 that may be observable by the operator at themeter 320 itself (or at the user interface 370). The operator maycompare the DC signal output to acceptable ranges defined based on trialdata for patients having similar physical characteristics as the patient(e.g., based on gender, age, height, or other applicable profile data).After the placement of the implant 170 is validated using DC signaloutput data generated based on the static load 345, the operator maythen provide an excitation (e.g., the test signals 340) and monitor theoutput parameters in the form of an indication of the frequency responseprovided by the implant based on its current location or placement. Ifthe frequency response is also within acceptable levels, the operatormay determine that the current location or placement of the implant 170is within acceptable parameters and conclude the surgical operationincluding removal of the sensor 230 by withdrawing the carrier plate 260from the implant 170 in the direction shown by arrow 395. After thecarrier plate 260 is withdrawn, the sensor 230 may be removed (alongwith any leads), and the carrier plate 260 may be reinserted into theimplant 170 (e.g., by motion opposite the direction of arrow 395).Meanwhile, the data associated with conclusion of this particularoperation may also be recorded so that the outcomes for the patient canbe evaluated and, over time, trend analysis may confirm existingacceptable ranges or the acceptable ranges can be modified.

FIG. 4 illustrates a block diagram of a method of employing a sensor forproviding feedback on implant placement during surgical procedures for amiddle ear implant in accordance with an example embodiment. The methodmay include placing a sensor on a carrier plate that is insertablewithin a portion of the implant or prosthetic at operation 400. Themethod may further include installing the carrier plate into the portionof the implant with communication to a test set at operation 410. Atoperation 420, the implant may be placed in the middle ear of a patient.At operation 430, a DC component may be detected at the meter indicativeof static pressure placed on the sensor based on its placement in themiddle ear. An AC component indicative of frequency response of theimplant may then be detected by the meter at operation 440. Any neededadjustments to implant location may be performed at operation 450 andthe AC and/or DC components may be rechecked as appropriate. Atoperation 460, the carrier plate may be removed from the implant toenable the removal of the sensor from the carrier plate. Thereafter, atoperation 470, the carrier plate may be reinstalled (without the sensor)into the portion of the implant.

Example embodiments therefore represent a design for a middle earimplant and corresponding test set for use with the implant. The middleear implant may include a first interface portion configured tointerface with a first structure of a middle ear of a patient, a secondinterface portion configured to interface with a second structure of themiddle ear of the patient, a shaft configured to connect the firstinterface portion and the second interface portion, and a sensordisposed at one end of the shaft, between the shaft and one of the firstinterface portion or the second interface portion. The sensor may beconfigured to provide a DC signal output indicative of static pressureon the sensor based on placement of the sensor between the first andsecond structures. The sensor may also be configured to provide an ACsignal output indicative of a frequency response of the implant inresponse to the sensor being coupled to an output device. The test setmay include the implant and a meter where the meter is configured tointerface with the sensor during the surgical procedure to provideindications to an operator regarding the DC and AC signal outputs. Byembedding the sensor in the implant, verification of optimal implantcompression (e.g., between the malleus and stapes) and likelihood ofhearing restoration (e.g., within 0-20 dB across the frequency range ofspeech) may be conducted during surgery. The real-time feedback providedvia the sensor may enable the surgeon to verify proper adjustment andpositioning of the implant during surgery instead of weeks or monthslater. Example embodiments may also enable training procedures to beconducted and monitored based on simulating environmental conditions andmonitoring surgeon performance relative to setting the implant in properlocation for simulated conditions.

In some embodiments, additional optional structures and/or features maybe included or the structures/features described above may be modifiedor augmented. Each of the additional features, structures, modificationsor augmentations may be practiced in combination with thestructures/features above and/or in combination with each other. Thus,some, all or none of the additional features, structures, modificationsor augmentations may be utilized in some embodiments. Some exampleadditional optional features, structures, modifications or augmentationsare described below, and may include, for example, installing theimplant such that the first structure is a malleus and the secondstructure is a stapes of the patient. Alternatively or additionally,some embodiments may include the sensor being disposed at a floor of areceiving opening formed in the second interface portion to receivemechanical forces imparted on the shaft. Alternatively or additionally,some embodiments may include the sensor being embodied as a sensinglayer configured to have a first electrical lead contact a top surfaceof the sensing layer and a second electrical lead contact a bottomsurface of the sensing layer to generate electrical impulses based onthe mechanical forces imparted on the shaft. In some cases, the sensorlayer may be formed from a patterned piezoelectric composite filmprovided as a polymer sheet, a contoured/dome-shaped polymer sheet, or asensor layer formed from a bundled series of piezoelectric nanofibers.In an example embodiment, the first and second electrical leads may beremoved prior to completing a surgical procedure during which theimplant is placed in the middle ear of the patient, and the sensor mayremain in the implant in an isolated state. Additionally oralternatively, the sensor may be configured to provide real-time dataindicative of output parameters generated based on placement of theimplant in the middle ear during a surgical procedure. Additionally oralternatively, the test set may further include an excitation unitconfigured to provide test signals for stimulating and evaluation of theAC signal output. Additionally or alternatively, the test set mayfurther include a control unit configured to control the excitation unitand the meter. Additionally or alternatively, the control unit comprisesa user interface configured to enable the operator to define stimuli forevaluation. Additionally or alternatively, the control unit may includeprocessing circuitry configured to evaluate the AC signal output and/orDC signal output relative to respective predefined ranges to determinewhether the placement of the implant results in the AC signal outputand/or the DC signal output being within the respective predefinedranges.

Many modifications and other embodiments of the inventions set forthherein will come to mind to one skilled in the art to which theseinventions pertain having the benefit of the teachings presented in theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the inventions are not to be limited to the specificembodiments disclosed and that modifications and other embodiments areintended to be included within the scope of the appended claims.Moreover, although the foregoing descriptions and the associateddrawings describe exemplary embodiments in the context of certainexemplary combinations of elements and/or functions, it should beappreciated that different combinations of elements and/or functions maybe provided by alternative embodiments without departing from the scopeof the appended claims. In this regard, for example, differentcombinations of elements and/or functions than those explicitlydescribed above are also contemplated as may be set forth in some of theappended claims. In cases where advantages, benefits or solutions toproblems are described herein, it should be appreciated that suchadvantages, benefits and/or solutions may be applicable to some exampleembodiments, but not necessarily all example embodiments. Thus, anyadvantages, benefits or solutions described herein should not be thoughtof as being critical, required or essential to all embodiments or tothat which is claimed herein. Although specific terms are employedherein, they are used in a generic and descriptive sense only and notfor purposes of limitation.

What is claimed is:
 1. A method of employing a removable sensor forproviding feedback on implant placement during surgical procedures for amiddle ear implant comprising: a first interface portion configured tointerface with a first structure of a middle ear of a patient; a secondinterface portion configured to interface with a second structure of themiddle ear of the patient; a shaft configured to connect the firstinterface portion and the second interface portion; a carrier plateconfigured to be removably mounted in one of the first interface portionor the second interface portion; and a removable sensor configured to beremovably mounted to one end of the shaft, between the shaft and one ofthe first interface portion or the second interface portion, theremovable sensor being configured to provide a DC component indicativeof static pressure on the removable sensor based on placement of theremovable sensor between the first and second structures, and provide anAC component indicative of a frequency response of the implant, whereinthe removable sensor comprises a sensing layer configured to have afirst electrical lead contact a top surface of the sensing layer and asecond electrical lead contact a bottom surface of the sensing layer,the method comprising: mounting the removable sensor on the carrierplate; installing the carrier plate into the implant with communicationto a meter; placing the implant in the middle ear of a patient;generating electrical impulses based on mechanical forces imparted onthe shaft; detecting, based on the generated electrical impulses, the DCcomponent at the meter; detecting, based on the generated electricalimpulses, the AC component at the meter; removing the carrier plate fromthe implant to enable removal of the removable sensor from the carrierplate; and reinstalling the carrier plate into the implant.
 2. Themethod of claim 1, further comprising adjusting placement of the implantbased on the detected DC and AC components.
 3. The method of claim 1,further comprising: evaluating at least one of the detected DC componentand the detected AC component relative to a respective predefined rangeto determine whether the placing of the implant results in the at leastone of the detected DC component and the detected AC component beingwithin the respective predefined range.